FDA alert after cough syrup puts 3 in hospital

Cufloc–D is known to be a ‘non–opioid’ cough suppressant, but FDA suspects the syrup consumed by the three Navi Mumbai patients contained high quantity of the substance

The Food and Drug Administration (FDA) has issued a state–wide alert against the sale of a particular brand of cough syrup after three Navi Mumbai residents who took it had to be hospitalised last week.

A three–year–old girl and her aunt, and an unrelated five–year–old girl started to feel breathless and "turned numb" after they separately consumed Cufloc–D cough syrup.
Cufloc–D is known to be a ‘non–opioid’ cough suppressant,buttestsofthethreepatients revealed they had consumed a syrup with high quantity of the compound, FDA officials said on Friday.

Opioid, which resembles opium in addictive properties and physiological effects, is used for making medicines, especially pain killers. As it is addictive, doctors prescribe medication containing opioid in selected cases and in very little amount. Cough syrups with the compound are almost never recommended for children.

Cufloc–D is manufactured by Unison Pharmaceuticals, a company based in Himachal Pradesh, and is marketed in Mumbai by Duram Pharmachem in Vidyavihar.

On Friday, FDA inspectors visited Duram Pharmachem’s office and learnt that it hadpurchased5,063bottlesofCuflocDlast month. Of the batch, 1,942 bottles have been sold to drug stores in different parts of thestate.Therestwereseizedfromthecompany’s warehouse in Bhiwandi.

TheFDAhasissueda"stop–salenotification" across the state. Samples of the syrup have been sent for tests to the Drug Control Laboratory in the Bandra Kurla Complex.

The first case came to light on July 20, when five–year–old Arya Gupta from became unconscious soon after taking a 5ml dose of the cough syrup at her home in Kamothe. A local paediatrician, Shailesh Kabra, had prescribed the medicine.

"Within moments of consuming the syrup,Aryabecamenumb.Wetriedtowake her up, but she just wouldn’t open her eyes," said her father, Atul. "She was put on an oxygen supply in the hospital."

A urine test later revealed high opioid content in the girl’s body. Arya was finally discharged on Wednesday.

On Thursday, another patient of Dr Kabra, three–year–old Aarti Gholap, was hospitalised with similar symptoms. "She was prescribed just 2.5ml of the syrup. She couldn’t breathe and was very drowsy – standard symptoms of opioid consumption," Dr Kabra said.

AartiwasalsoadmittedtoSaiChildCare Clinic in a critical condition. She is still recovering. Aarti’s 21–year–old aunt, Poonam Kad, also fell ill on Thursday after taking the cough syrup from the same bottle. Both consumed it the same time, but Poonam becamebreathlessanddrowsytwohours later.

"She had a bit of cough and cold. She didn’t visit a doctor, and decided to follow Aarti’s medication," said Poonam’s brother, Sandeep. She was treated at Metro Hospital.

Three back–to–back cases prompted Dr Kabra to alert the FDA. "The bottles must have high quantityofopioidaslowdosages donotcausesuchseverereactions,"hesaid.

FDA Assistant Commissioner Vijay Karande, meanwhile, said that a stop–sale notice for Cufloc D had been sent to all drug stockists. "We have also recalled the bottles from across the state," he said.

Anand Uppal, a partner at Unison Pharmaceuticals, said that the company had sent quality test reports of Cufloc D to Duram Pharmachem, which would forward them to the FDA.

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